Contacts

Development

With a leadership position in cell biology, virology and molecular biology, and in strict compliance with current legislation regulating the production of patient-specific cells, genetically modified cells and viral vectors for clinical use, MolMed GMP Solutions provide customers with a full range of services.

Molmed's excellent drug development scientists, technicians and project leaders provide a unique expertise to reach the goal you expect from your projects. They will work with you closely to single out the best conditions and raw materials to identify sound and reliable processes suitable for subsequent scale-up and transfer to GMP production.
During the development phase, manufacturing and analytical methods are developed and optimized to produce the required biotechnology products on large scale, evaluating their potency and other critical features.
The methods and processes are designed and the specifications established in order to comply with current regulations for biotechnology products and advanced therapy medicinal products.

Process development includes many activities such as preparation of stable cell clones specifically for retroviral vector production, cloning of hybridoma or other cell lines, optimization of cell culture conditions and adaptation to serum-free growth conditions, manufacturing of retroviral and lentiviral vectors in flasks, cell factories and bioreactors.
Other activities include purification processes for retroviral and lentiviral vectors, antibodies and recombinant proteins or the depletion of cell populations from primary cultures.

Analytical method development includes cell assays, such as cell viability, proliferation, toxicity, apoptosis and cell cycle, immunoassays with ELISA and flow cytometry, microbiology testing for sterility, mycoplasma and endotoxins, virology assays such as RCR, RCL and viral titer determination, and molecular biology assays such as PCR, RT-PCR, PCR, quantitative, Northern Blot and Southern Blot.

In the development laboratories, high quality pre-GMP materials can also be produced on a small or large scale, sterile and with low endotoxin content, ready for use in research, development and preclinical studies. In particular retroviral and lentiviral vectors as well as stocks of primary cells with or without genetic modification, monoclonal antibodies and recombinant proteins from mammalian cells can be developed, produced and scaled-up.

MolMed S.p.A. Via Olgettina, 58 - 20132 Milano, Italy | Phone +39 0221277.1 - Fax +39 02 21277.325 | info@molmed.com - www.molmed.com
Share capital € 20,312,682.30 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159